ZURICH (Reuters) – Roche expects its risdiplam medicine for spinal muscular atrophy (SMA) to get U.S. approval by May, the Swiss drugmaker said on Monday, as it takes on Novartis and Biogen in the lucrative rare disease area.
The U.S. Food and Drug Administration granted priority review for risdiplam, an oral medicine for those with the potentially deadly muscle-wasting disorder. Roche, whose drug is seen as a rival for Biogen’s Spinraza and Novartis’s Zolgensma gene therapy, said the FDA is due to decide by May 24.
Roche is seeking broad approval for people into adulthood with different forms of SMA, including the deadly Type 1 disease that kills many infants in their first months of life as well as Type 3 disease that may set in later but still leaves its victims with profound physical disabilities.
SMA is becoming a hard-fought battleground for drugmakers, as urgent need for treatments has helped lead to some of the highest prices in the pharmaceuticals industry. …
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